Arni Medica is a leading medical device manufacturer specializing in contract manufacturing, current product development, and high-quality production of nephrology and healthcare products. We are looking for motivated and detail-oriented fresh graduates to join our Regulatory Affairs (RA) team. This role offers exposure to medical device regulations, product registrations, technical documentation, and compliance processes.

Requirements

- Assist in preparation and compilation of regulatory dossiers for medical devices.

- Support product registration and licensing activities with regulatory authorities (CDSCO and other global markets).

- Maintain and organize technical documentation, Device Master Files (DMF), and regulatory records.

- Ensure compliance with applicable regulatory standards and guidelines.

- Assist in Labelling review, IFU (Instructions for Use), and artwork compliance checks.





- Support change control documentation and regulatory impact assessments.

- Coordinate with QA, R&D;, and production teams for regulatory submissions.

- Track regulatory submissions, approvals, and renewals.

- Assist in handling queries from regulatory bodies and auditors.

- Maintain regulatory databases and ensure timely updates.

Skills Required:

- Basic knowledge of medical device regulations and documentation

- Understanding of ISO 13485 and regulatory compliance (preferred)

- Strong attention to detail and documentation skills

- Good communication and coordination abilities

- Willingness to learn regulatory processes and global requirements

📌 Jr RA Executive (Patancheruvu)
🏢 Arni Medica
📍 Patancheruvu